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Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646191
First Posted: March 28, 2008
Last Update Posted: March 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Condition Intervention Phase
Psoriasis Drug: adalimumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Extension Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Psoriasis Area and Severity Index [ Time Frame: Week 12 ]
  • Adverse Events [ Time Frame: Throughout Study Participation ]

Secondary Outcome Measures:
  • Psoriasis Area and Severity Index [ Time Frame: Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48 ]
  • DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS [ Time Frame: Week 12, 24 and 48 ]
  • Physician's Global Assessment [ Time Frame: Week 12, 16, 20, 24, 32, 40 and 48 ]

Enrollment: 137
Study Start Date: March 2003
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: adalimumab
40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
Other Names:
  • ABT-D2E7
  • Humira
Active Comparator: B Drug: adalimumab
40 mg weekly through Week 48 (OL Week 12 - 48)
Other Names:
  • ABT-D2E7
  • Humira
Active Comparator: C Drug: adalimumab
80 mg W0, 40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
Other Names:
  • ABT-D2E7
  • Humira

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject completed prior PS study

Exclusion Criteria:

  • Subject has other active skin diseases
  • Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
  • Poorly controlled medical conditions
  • History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
  • History of cancer or lymphoproliferative disease
  • History of active TB or listeriosis, or persistent chronic or active infections
  • Known to have immune deficiency or is immunocompromised
  • Clinically significant abnormal laboratory test results
  • Erythrodermic psoriasis or generalized pustular psoriasis
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Beverly Paperiello / Director, Clinical Program Management, Abbott
ClinicalTrials.gov Identifier: NCT00646191     History of Changes
Other Study ID Numbers: M02-529
First Submitted: March 26, 2008
First Posted: March 28, 2008
Last Update Posted: March 28, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents